evaluation of dupilumab in children with uncontrolled asthma

Conditions: Asthma

Summary: primary objective: to evaluate the efficacy of dupilumab in children 6 to less than (\<) 12 years of age with uncontrolled persistent asthma. secondary objective: to evaluate in children 6 to \<12 years of age with uncontrolled persistent asthma: * the safety and tolerability of dupilumab. * the evaluate the effect of dupilumab in improving participant reported outcomes including health related quality of life. * the dupilumab systemic exposure and incidence of anti-drug antibodies. * the evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.

the total study duration per participant was up to 69 weeks, consisted of a screening period of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12 weeks.

Eligibility criteria:
inclusion criteria : children 6 to \ =)12 months prior to screening, based on clinical history and examination, pulmonary function parameters according to global initiative for asthma (gina) 2015 guidelines and the following criteria: * existing background therapy of medium-dose ics with second controller medication (i.e., long-acting β2 agonist , leukotriene receptor antagonist, long acting muscarinic antagonist, or methylxanthines) or high-dose ics alone or high-dose ics with second controller, for at least 3 months with a stable dose \>=1 month prior to screening visit 1. * pre-bronchodilator forced expiratory volume in 1 second (fev1) \<=95 percentage (%) of predicted normal or pre bronchodilator fev1/forced vital capacity ratio \<0.85 at screening and baseline visits. * reversibility of at least 10% in fev1 after the administration of 200 to 400 micrograms (mcg; 2 to 4 puff inhalations with metered-dose inhaler \[mdi\]) of albuterol/salbutamol or 45 to 90 mcg (2 to 4 puffs with mdi) of levalbuterol/levosalbutamol reliever medication before randomization (up to 3 opportunities during the same visit were allowed with a maximum of 12 puffs of reliever medication if tolerated by the participant). * must had experienced, within 1 year prior to screening visit 1, any of the following events: * treatment with a systemic corticosteroid (oral or parenteral), as prescribed by a healthcare professional for worsening asthma at least once or, * hospitalization or emergency visit for worsening asthma. * evidence of uncontrolled asthma, with at least one of the following criteria during the 4 (±1) weeks screening period: * asthma control questionnaire-interviewer administered (acq-ia) acq-5 score \>=1.5 on at least one day of the screening period. * use of reliever medication (i.e., albuterol/salbutamol or levalbuterol/levosalbutamol), other than as a preventive for exercise induced bronchospasm, on 3 or more days per week, in at least one week during the screening period. * sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the screening period. * asthma symptoms 3 or more days per week in at least one week during the screening period. exclusion criteria: * participants \ =12 years of age. * participants with \<16 kg bodyweight. * any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc.), which may impair lung function. * a participant with any history of life threatening asthma (ie, extreme exacerbation that requires intubation). * co-morbid disease that might interfere with the evaluation of investigational medicinal product. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.